Evaluation of Virtual Reality Glasses Use During Inhaler Treatment in Children

February 29, 2024 updated by: Berker Okay, Haseki Training and Research Hospital

Virtual reality (VR) glasses are technological devices that are often used in medical fields recently and are seen as suitable for distracting children. In the last few years, many studies have been conducted to facilitate pediatric patients against painful or frightening medical procedures. For uncomfortable procedures, distracting the child's attention is seen as the most important point. VR technology has been used for procedures such as burn cases, tooth extraction, intramuscular injection, intravenous cannula, lumbar puncture, and the results of the research have been found to be satisfactory. Using VR glasses alone or in combination with standard care is effective in reducing pain and anxiety. So far, there is no study in the literature on distraction with VR during inhaler treatment in pediatric patients. Children cannot receive inhaler treatment efficiently due to reasons such as restlessness, crying, and pulling the mask during inhaler treatment, and their hospital stay is prolonged. In this study, the investigators planned to compare the patients who received inhaler treatment with VR glasses with the patients who received treatment without the aid of any device in terms of treatment compliance.

Thus, the investigators aimed to make the inhaler treatment more comfortable with VR technology.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study was designed by including children aged 2-5 years, who needed inhaler treatment (salbutamol) between 10.11.2022 and 01.04.2023, whose families gave consent for the study. This age group (preschool) was chosen because it is the age group that presents the most difficulties to families and physicians during inhaler treatment and screen exposure does not cause problems up to a certain point. The study was conducted as a prospective, single-blind, randomized, controlled study in the Pediatric Emergency Department of the Health Sciences University Haseki Training and Research Hospital.

Children with neuromotor retardation, visual and auditory problems, underlying chronic diseases (bronchiolitis, chronic lung diseases other than asthma, congenital heart diseases, neurological diseases such as epilepsy), obesity or malnutrition (to equalize the effectiveness of the drug dose), adrenaline, budesonide or Those who receive ipratropium bromide treatment, those who will receive inhaler nebula treatment for the first time, those who have received inhaler treatment in the last 72 hours, those who have a previous operation or sedative history, those who have a fever above 37.5°C, those who have used VR before, those under 2 years of age to avoid screen exposure children (infants) and children over 5 years old (school period) were excluded from the study. In addition, children with a saturation value below 92% at the time of admission, those presenting with severe asthma attacks and those with respiratory failure symptoms were not included in the study. Children with a score of 5 and above according to the bronchiolitis severity score were excluded from the study.

The children included in the study were divided into 3 groups by randomization method: VR audio-visual users (Roller Coasters, group 1), VR audio-visual users (Wild Dolphins, group 2) and those who did not use any additional equipment. (group 3). These children were observed during their 15-minute inhaler treatment and the groups were compared in terms of crying times, changes in RR, SpO2, HR values with pre- and post-treatment physician questionnaires and family questionnaires.

In the comparison study of Gerceker et al., with VR glasses in children from whom blood was drawn, the pain score was found to be 1.2 ± 2.2 in children using VR glasses, and 4.1 ± 3.5 in children without VR (control group), and the standard effect size was determined as 0.99 in the power analysis based on these data. When the number of 45 cases in each group is taken, the power of the study was calculated to be with a 1% margin of error and 98% power.

During the study period (November 2022 - April 2023), 913 children received inhaler treatment in our hospital. Children who met the selection criteria and whose families agreed to participate in the study were included in the study, and the study was terminated when the target number of 135 children was reached. 689 children who did not meet the inclusion criteria (such as chronic disease or severe bronchiolitis) and were not suitable for their age (such as under 2 years old, over 5 years old) were excluded from the study. Of the 224 children who met the inclusion criteria, 89 were excluded because they refused to participate in the study.

The children to be included in the study were determined by randomization method. For randomization, the site named randomizer.org was used to randomize 3 different groups. A computer-generated block method divided children into 3 groups (VR glasses roller coaster, VR glasses wild dolphins, and control). Based on 45 randomly sorted sets (1, 2, 3) (eg Set 1 Group 2, Set 2 Group 3, Set 3 Group 1), a total of 135 unique codes were generated and then randomly placed in a blocking box. protected. Only the second researcher knew the group value of the sets.

The children included in the study were divided into 3 groups: VR audio-visual users (Roller Coasters, group 1), VR audio-visual users (Wild Dolphins, group 2), and those who did not use any additional equipment (group 3). 3D Roller Coasters and 3D Wild Dolphins videos were used as VR images via Youtube application (Google LLC. California, USA; Youtube®). VR glasses were integrated into the tablet and given to the accompanying parent, so that the parent could see what their child was watching at that moment.

Children in all groups were given 'salbutamol' inhaler treatment for 15 minutes, and equality was achieved between the groups in terms of treatment active substance and duration. Salbutamol was given to each child as 2.5 mg/2.5 ml. The children were observed during their 15-minute inhaler treatment, and the crying times were compared with the anxiety scoring made by the same doctor before and after the treatment, and the minute respiratory rate (RR), oxygen saturation (SpO2), heart rate change (HR) and the duration of inhaler treatment were compared. In addition, families filled out questionnaires about their children's mental state before and after the treatment. The FLACC (Face, Legs, Activity, Cry, consolability) Pain Assessment Scale was used for the anxiety scoring made by the physician, and the Yale Modified Anxiety Scale (MYPAS), which was thought to be appropriate for our study, although it was designed to measure pre-operative anxiety. For families, a form consisting of eight 'yes-no' questions called the Parents' Pain Measure (MPPM), modified by us and normally used for post-operative anxiety/pain measurement, was used. In addition, Wong Baker Faces Pain Rating Scale (WBS) was also used to evaluate the anxiety of the children for convenience to the family.

The children to be included in the study were determined by a single researcher. The first investigator identified the children who met the inclusion criteria, noted the FLACC and MYPAS score, as well as the RR, SpO2, and HR values, and referred the child to the other investigator. The second investigator divided the child into his group using the randomization method, and determined the duration of crying and effective treatment, along with the duration of treatment, with a double chronometer during treatment. At the end of the treatment, the family and the child were re-directed to the first researcher on the condition that they did not tell the first researcher which group they were in. Thus, it was ensured that the first investigator did not know which group the child belonged to while filling in the FLACC and MYPAS score before and after the treatment and determining SpO2, RR and HR. In addition, with the MPPM and WBS performed by the families, the changes in the children's discomfort/restlessness were determined from the family's point of view before and after the treatment.

Newly opened sterile masks were used for inhalation therapy in each child. In order to standardize the treatment, the 'Omron® CompAIR Pro NE-C900 Compressor Nebulizer' was used as a nebulizer. After each child, the infected materials of the VR glasses were removed with a surface disinfectant containing didecyldimethylammonium chloride and left in a disinfectant containing non-abrasive quarter ammonium carbonate, non-ionic surface active material and enzymatic complex, then rinsed with distilled water and waited until dry.

Study Type

Interventional

Enrollment (Actual)

135

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Sultangazi
      • Istanbul, Sultangazi, Turkey, 34304
        • UHS Haseki Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Between 2-5 years old
  • Children who need inhaler treatment (salbutamol)
  • Children whose families give consent to participants the study

Exclusion Criteria:

  • Children with neuromotor retardation,
  • Visual and auditory problems,
  • Underlying chronic diseases (bronchiolitis, chronic lung diseases other than asthma, congenital heart diseases, neurological diseases such as epilepsy),
  • Obesity or malnutrition (to equalize the effectiveness of the drug dose),
  • Adrenaline, budesonide or those who receive ipratropium bromide treatment,
  • Those who will receive inhaler inhaler treatment for the first time,
  • Those who have received inhaler treatment in the last 72 hours,
  • Those who have a previous operation or sedative history,
  • Those who have a fever above 37.5°C,
  • Those who have used VR before,
  • Patients with a saturation value below 92% at the time of admission,
  • Those presenting with severe asthma attack,
  • Those with respiratory failure symptoms,
  • Patients with a score of 5 and above according to the bronchiolitis severity score
  • Those under 2 years of age to avoid screen exposure patients (infants) and patients over 5 years old (school period)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Roller Coasters, group 1
VR audio-visual users with Roller Coasters
Device: Virtual Reality audio and visual glass (Roller Coasters, group 1)
During the inhaler treatment, the child was shown Roller Coasters with VR glasses.
Experimental: Wild Dolphins, group 2
VR audio-visual users with Wild Dolphins
Device: Virtual Reality audio and visual glass (Wild Dolphins, group 2)
During the inhaler treatment, the child was shown Wild Dolphins with VR glasses.
No Intervention: group 3
did not use any additional equipment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the FLACC (Face, Legs, Activity, Cry and Consolability ) pain scoring system
Time Frame: Baseline
Changing pain scores by helping with uncomfortable procedures for children. The researchers used the FLACC (Face, Legs, Activity, Cry and Consolability ) scoring and scored between 0 and 10. A higher score indicated more pain and restlessness.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haseki Training and Research Hospital

Investigators

  • Principal Investigator: Berker Okay, M.D., Member

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2022

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

April 1, 2023

Study Registration Dates

First Submitted

April 7, 2023

First Submitted That Met QC Criteria

April 20, 2023

First Posted (Actual)

May 3, 2023

Study Record Updates

Last Update Posted (Actual)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22/197

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The IPD are available from the principal investigator upon reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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